Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Febuxostat Between TMX-67 40mg 2 Tablets and Feburic® 80mg 1 Tablet in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01563432

Enrollment

Registered

2012-03-27

Start date

2012-01-31

Completion date

2012-02-29

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

crossover, pharmacokinetic, hyperuricemia, gout

Brief summary

This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.

Interventions

DRUGFeburic®

80 mg\*1 tablet

DRUGTMX-67

40 mg\*2 tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult males aged between 20 and 45 years * Subjects whose weight is 50 kg or more and BMI is between 18 and 29 kg/m2 * Subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions

Exclusion criteria

* Medical history which may influence adsorption, distribution, metabolism, excretion of the drug * Clinically significant active chronic disease(s) * Persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic characteristics (AUClast and Cmax)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026